MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752449

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that the trocars leaked during a procedure.The pressure was increased to 60 mmhg to compensate and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of a pak label, the reported product and lot information is confirmed.Because a sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11756831
• MDR Text Key: 248860445
• Report Number: 1644019-2021-00299
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524495
• UDI-Public: 00380657524495
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 8065752449
• Device Lot Number: 2362934H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1